This clinical trial is focused on studying the effects of a treatment called zilovertamab vedotin in children and young adults who have certain types of cancers. These cancers include hematologic malignancies, which are cancers that start in blood-forming tissue, and solid tumors, which are abnormal masses of tissue. The specific types of cancers being studied are B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma, neuroblastoma, and Ewing sarcoma. The treatment, zilovertamab vedotin, is given as a solution through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.
The purpose of this study is to evaluate the safety and effectiveness of zilovertamab vedotin in treating these cancers. The study is divided into two parts. In the first part, the focus is on understanding how safe the treatment is and how well it is tolerated by participants aged 1 to under 18 years. The second part looks at the treatment’s ability to reduce or eliminate the cancer in participants from birth to 25 years old. The study will monitor participants for any side effects and how their cancer responds to the treatment.
Participants in the study will receive either the treatment or a placebo. The study will track various outcomes, such as the number of participants who experience side effects, the number who need to stop the treatment due to side effects, and the number who need to change their dose. The study will also look at how the treatment affects the cancer, including whether it helps reduce the size of the tumors or leads to remission. The study is expected to continue until 2029, providing valuable information on the potential benefits and risks of using zilovertamab vedotin for these types of cancers in young patients.



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